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Recall Category: Medical Device Recalls
Recalling Firm: Olympus Corporation of the Americas
Product: Product Name: Disposable Triple Lumen Sphincterotome Model/Catalog Number: KD-401Q-0330 Product Description: These instruments have been designed to be used with an Olympus endoscope and guidewire for papillotomy using high-frequency current.
Reason for Recall: Devices which did not undergo thermoforming could deform and lose performance.
Classification: Class II
Status: Ongoing
Report Date: 02/11/2026
Recall Initiation Date: 01/07/2026
Distribution: Worldwide – US Nationwide distribution including in the states of AL, AR, AZ, CA, CO, DC, DE, FL, GA, GU, HI, IA, IL, IN, KY, LA, MA, MD, MI, MN, MO, MS, MT, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, RI, SC, SD, TN, TX, UT, VA, WA, WI, WV, WY and International: TBD.
Code Info: Model/Catalog Number: KD-401Q-0330; Material REF: 5856730; UDI-DI: 04953170041617; All Lots with a valid expiration date
Product Quantity: 886 units (OUS only)
Recall Type: Voluntary: Firm initiated
Initial Firm Notification: Letter
Firm Location: Center Valley, PA, United States
Recall Number: Z-1287-2026
Event ID: 98252